STERIS ISOMEDIX PUERTO RICO, INC.

Contract sterilizer · Alts De Cerro Gordo 3&4, PR

FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified

FDA registration: 2648623 (openFDA record; or search FDA's registration database)
FEI number: 2648623
Registered for: FDA registration year 2026
Establishment types: Contract sterilizer
Owner or operator: STERIS Corporation (FDA owner/operator no. 1527821)
Registered address: KM 1 7, STATE Road, 690, BARRIO SABANA HOYOS, Alts De Cerro Gordo 3&4, PR 00692
Contract listings: 86 device listings, 63 product codes, first listed Oct 31, 2012
Certification: Not verified. We have no certification data for this facility yet.

Devices listed as contract work

Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.

Product code	Device (FDA name)	Class	Category	Role	First listed
BYY	Tube, Aspirating, Flexible, Connecting	Class II	General hospital	Contract sterilization	Nov 15, 2012
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Class II	Cardiovascular	Contract sterilization	Nov 7, 2012
DXC	Clamp, Vascular	Class II	Cardiovascular	Contract sterilization	Dec 20, 2021
EQJ	Bur, Ear, Nose And Throat	Class I	Ear, nose and throat	Contract sterilization	Oct 19, 2020
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Class II	Ear, nose and throat	Contract sterilization	Oct 19, 2020
FQH	Lavage, Jet	Class II	General hospital	Contract sterilization	Dec 27, 2012
GAD	Retractor	Class I	General and plastic surgery	Contract sterilization	Sep 11, 2013
GAL	Suture, Absorbable, Natural	Class II	General and plastic surgery	Contract sterilization	Nov 8, 2012
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	Class II	General and plastic surgery	Contract sterilization	Nov 8, 2012
GAP	Suture, Nonabsorbable, Silk	Class II	General and plastic surgery	Contract sterilization	Nov 8, 2012
GAQ	Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile	Class II	General and plastic surgery	Contract sterilization	Nov 8, 2012
GAR	Suture, Nonabsorbable, Synthetic, Polyamide	Class II	General and plastic surgery	Contract sterilization	Nov 8, 2012
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	Class II	General and plastic surgery	Contract sterilization	Nov 8, 2012
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	Class II	General and plastic surgery	Contract sterilization	Nov 8, 2012
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	Class II	General hospital	Contract sterilization	Dec 18, 2012
GDW	Staple, Implantable	Class II	General and plastic surgery	Contract sterilization	Nov 6, 2012
GDX	Scalpel, One-Piece	Class I	General and plastic surgery	Contract sterilization	Dec 27, 2012
GDY	Gauze/Sponge, Internal, X-Ray Detectable	Class I	General and plastic surgery	Contract sterilization	Oct 19, 2020
GEI	Electrosurgical, Cutting & Coagulation & Accessories	Class II	General and plastic surgery	Contract sterilization	Dec 18, 2012
GES	Blade, Scalpel	Class I	General and plastic surgery	Contract sterilization	Dec 27, 2012
GFA	Blade, Saw, General & Plastic Surgery, Surgical	Class I	General and plastic surgery	Contract sterilization	Jan 7, 2013
HBB	Motor, Drill, Pneumatic	Class II	Neurology	Contract sterilization	Dec 20, 2012
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Class II	Neurology	Contract sterilization	Jul 31, 2022
HDH	Needle, Cerclage, Gynecological	Class I	Obstetrics and gynecology	Contract sterilization	Aug 22, 2023
HET	Laparoscope, Gynecologic (And Accessories)	Class II	Obstetrics and gynecology	Contract sterilization	Dec 18, 2012
HRX	Arthroscope	Class II	Orthopedic	Contract sterilization	Dec 18, 2012
HTW	Bit, Drill	Class I	Orthopedic	Contract sterilization	Dec 27, 2012
HWC	Screw, Fixation, Bone	Class II	Orthopedic	Contract sterilization	Dec 18, 2012
JDW	Pin, Fixation, Threaded	Class II	Orthopedic	Contract sterilization	Dec 18, 2012
JDZ	Mixer, Cement, For Clinical Use	Class I	Orthopedic	Contract sterilization	Nov 16, 2012
KDC	Instrument, Surgical, Disposable	Class I	General and plastic surgery	Contract sterilization	Jan 8, 2013
KDD	Kit, Surgical Instrument, Disposable	Class I	General and plastic surgery	Contract sterilization	Dec 28, 2012
KNW	Instrument, Biopsy	Class II	Gastroenterology and urology	Contract sterilization	Dec 18, 2012
KPE	Container, I.V.	Class II	General hospital	Contract sterilization	Nov 15, 2012
KQT	Evacuator, Gastro-Urology	Class II	Gastroenterology and urology	Contract sterilization	Dec 18, 2012
KWP	Appliance, Fixation, Spinal Interlaminal	Class II	Orthopedic	Contract sterilization	Sep 11, 2013
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Class II	Orthopedic	Contract sterilization	Sep 11, 2013
LDF	Electrode, Pacemaker, Temporary	Class II	Cardiovascular	Contract sterilization	Aug 22, 2023
LJH	System, Irrigation, Urological	Class II	Gastroenterology and urology	Contract sterilization	Oct 19, 2020
LMG	Agent, Absorbable Hemostatic, Non-Collagen Based	Class III	General and plastic surgery	Contract sterilization	Mar 8, 2013
LOD	Bone Cement	Class II	Orthopedic	Contract sterilization	Oct 19, 2020
LPB	Cardiac Ablation Percutaneous Catheter	Class III	Cardiovascular	Contract sterilization	Nov 7, 2012
LWQ	Heart-Valve, Mechanical	Class III	Cardiovascular	Contract sterilization	Nov 7, 2012
LXH	Orthopedic Manual Surgical Instrument	Class I	Orthopedic	Contract sterilization	Oct 31, 2012
LZN	Cement Obturator	Class II	General and plastic surgery	Contract sterilization	Dec 18, 2012
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Class II	Orthopedic	Contract sterilization	Sep 30, 2022
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Class II	Orthopedic	Contract sterilization	Dec 12, 2019
MCN	Barrier, Absorbable, Adhesion	Class III	Obstetrics and gynecology	Contract sterilization	Nov 8, 2012
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Class II	Orthopedic	Contract sterilization	Sep 11, 2013
MNI	Orthosis, Spinal Pedicle Fixation	Class II	Orthopedic	Contract sterilization	Sep 11, 2013
MQP	Spinal Vertebral Body Replacement Device	Class II	Orthopedic	Contract sterilization	Sep 11, 2013
NBH	Accessories, Arthroscopic	Class I	Orthopedic	Contract sterilization	Dec 27, 2012
NDN	Cement, Bone, Vertebroplasty	Class II	Orthopedic	Contract sterilization	Dec 18, 2012
NKB	Thoracolumbosacral Pedicle Screw System	Class II	Orthopedic	Contract sterilization	Sep 11, 2013
NKG	Posterior Cervical Screw System	Class II	Orthopedic	Contract sterilization	Sep 11, 2023
OAR	Injector, Vertebroplasty (Does Not Contain Cement)	Class I	Orthopedic	Contract sterilization	Dec 27, 2012
OCJ	Spinal Channeling Instrument, Vertebroplasty	Class I	Orthopedic	Contract sterilization	Oct 19, 2020
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Class II	Orthopedic	Contract sterilization	Dec 14, 2022
OLO	Orthopedic Stereotaxic Instrument	Class II	Neurology	Contract sterilization	Jul 31, 2022
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Class II	Orthopedic	Contract sterilization	Aug 28, 2014
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Class II	Orthopedic	Contract sterilization	Dec 14, 2022
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Class II	Orthopedic	Contract sterilization	Mar 24, 2023
PML	Bone Cement, Posterior Screw Augmentation	Class II	Orthopedic	Contract sterilization	Sep 20, 2023

STERIS ISOMEDIX PUERTO RICO, INC.

Devices listed as contract work

Other contract facilities of STERIS Corporation